Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adults with head and neck cancer. This study assesses the efficacy and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with NSCLC. This is a randomized, muti-center sites trial of this treatment.
This is a randomized, muti-center sites trial of Nimotuzumab combination with Paclitaxel Liposome and Carboplatin (TP regimen) treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
1. TP Regims:Paclitaxel Liposome,135mg/m2,d1;Carbopatin(AUC=5) d2, 3 weeks/cycle, for 4 cycles. 2. Nimotuzumab: 200mg/w, weekly, for 6 weeks; Consolidation treatment, 200mg every 2 weeks, until the end of 4 cycles of chemotherapy or the disease progression.
TP Regimen:Paclitaxel Liposome,135mg/m2,d1;Carbopatin(AUC=5) d2, 3 weeks/cycle,for 4 cycles.
Tianjian Medical University Cancer Institue and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGProgression-free survival
Time frame: 12months
Overall survival Time
Time frame: 3 years
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